Shire steps away from biosimilars

Shire has handed back rights to the two biosimilars it acquired through its recent purchase of Baxalta, retaining its focus on the development of drugs for rare diseases.

The UK-based group is returning global development and commercialisation rights to M923, a proposed biosimilar of Humira (adalimumab), to US group Momenta Pharmaceuticals, but will continue to fund the programme for 12 months as per the original deal with Baxalta.

"We view Shire's decision as a significant opportunity for us to capture additional value from this program for the Company and its shareholders. We remain very excited about the potential for our biosimilar HUMIRA candidate and look forward to reporting top-line results of the current Phase III trial of M923 in late 2016," said Momenta's president and chief executive, commenting on the move.

US biotech Coherus BioSciences has also regained from Shire all development and commercial rights previously licensed for CHS-0214 etanercept, a biosimilar candidate to Enbrel, for Europe, Canada, Brazil, the Middle East and other territories.

The drug has successfully completed two Phase III studies, in chronic plaque psoriasis and rheumatoid arthritis, data from which will support its European marketing application, planned for the fourth quarter of this year.

"These reacquired geographical rights fit well with our existing US CHS-0214 rights, and we now have the opportunity to license throughout Europe, US and other key commercial geographies two complimentary Anti-TNF assets - CHS-0214, an Enbrel biosimilar candidate and CHS-1420, a Humira biosimilar candidate".